This International Standard specifies requirements for a quality
management system where an organization
a) needs to demonstrate its ability to consistently provide
product that meets customer and applicable statutory and regulatory
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for continual
improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term "product" only
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization
NOTE 2 Statutory and regulatory requirements can be expressed as
All requirements of this International Standard are generic and
are intended to be applicable to all organizations, regardless of
type, size and product provided.
Where any requirement(s) of this International Standard cannot
be applied due to the nature of an organization and its product,
this can be considered for exclusion.
Where exclusions are made, claims of conformity to this
International Standard are not acceptable unless these exclusions
are limited to requirements within Clause 7, and such exclusions do
not affect the organization's ability, or responsibility, to
provide product that meets customer and applicable statutory and